Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
HCP experienced an accidental needle stick after drawing up TICE BCG and prior to administration to a patient. HCP reports 18 gauge non Merck needle punctured her left thumb.; HCP confirmed full dose still in syringe so likely exposed to just a trace amount"; This spontaneous report was received from another health professional regarding to a 40-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Bacillus of Calmette and Guerin live (TICE BCG), (indication, dose, frequency, route of administration, expiration date, and lot # were not reported). On 12-Nov-2025, the patient (health care professional) experienced an accidental needle stick after drawing up TICE BCG and prior to administration to a patient (injury associated with device). Moreover, she reported that 18-gauge non-Merck needle punctured her left thumb. Therefore, she confirmed that full dose stilled in syringe, so she was likely exposed to just a trace amount (accidental exposure to product). At the reporting time, the outcome of the events was unknown. The action taken with BCG TICE regarding the events was assessed not applicable. The causal relationship between the events and TICE BCG was not provided. Lot number is being requested and will be submitted if received.